Kornimate/medical-research-clean huggingface dataset:
endoluminale obliteration der stammvene mit dem 1470nm laser versus vnus closure fast

Conditions: Venous Insufficiency

Summary: there is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or vnus closure fast (=radiofrequency method) .

the endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. there are different methods that cause an obliteration of the vein using heat. the adventage of these methods are low rates of minor and major complications compared to classic open surgery. there are also advantages concerning cosmetic and recurrence of varicous veins. actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. the objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. all patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. there are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment. in this study there are no additional risk factors for the included study patients except the risk of surgery.

Eligibility criteria:
inclusion criteria: * varicosis of great saphenous vein hach-classification ii-iii (ceap-classification: c3-4epas2-3pr and/or varicosis of small saphenous vein der hach-classification i-iii ceap-classification: c3-4epas4pr) * maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm exclusion criteria: * surgical treatment of the saphenous vein in the past * sclerotherapy of the saphenous vein in the past * phlebitis or thrombosis of the saphenous vein * surgical treatment of an venous ulcer in the past * postthrombotic syndrome * erysipelas of the leg in the past * chronic treatment with pain-killers or chronic alcoholism * pregnancy * drug allergy against painkillers that are used in this study * spinal anesthesia not possible * compression bandage not possible * patients with polyneuropathy * patients with chronic pain * persons that do have a connection or persons that are working for one of the jused companies (laser or vnus closure fast) * participation on an other clinical trial that can interfere with this clinical trial * missing written informed consent

Keywords: endovenous treatment laser, vnus closure fast varicosis great saphenous vein small saphenous vein venous insufficiency
connective tissue manipulation and combined ultrasound therapy in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with fibromyalgia.

this is an observational prospective cohort study, investigating short and long term results of physiotherapy applications in 20 female patients with fibromyalgia. physical characteristics of the subjects were recorded. intensity of pain, complaint of non-restorative sleep, and impact of fibromyalgia on functional activities were evaluated by visual analogue scales. all evaluations were performed before and after 20 sessions of treatment, which included connective tissue manipulation of the back daily, for a total of 20 sessions and combined ultrasound therapy of the upper back region every other session. one year follow-up evaluations could be performed on 14 subjects.

Eligibility criteria:
inclusion criteria: women with pain depending to fm, with an intensity interfering to activities of daily living for a duration of at least six months, able to participate of 20 physiotherapy sessions within a four week period, volunteer for participating to the study without taking any drugs acting on the nervous system such as antidepressants, myorelaxants, analgesics or hypnotics, in the study period. exclusion criteria: evidence of neurological, infectious, endocrine and other inflammatory rheumatic diseases, and experience with any kind of manual and/or electrotherapy, within six months before the study.

Keywords: fibromyalgia connective tissue manipulation ultrasound therapy high voltage pulsed galvanic stimulation
effects of music therapy on psychological states among cancer patients undergoing mri scans and a relevant mediator

Conditions: Psycho-Oncology

Summary: the primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through mri scanning. physiological data, such as pulse rates and respiration rates will be collected. furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. the secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation.

to assess the protocol, recruited participants will be randomly allocated into two groups: a control group or a music therapy group. participants in the control group will receive standard care as usual, and they will be offered music therapy interventions upon their request during subsequent appointments. participants in the music group will receive standard care and music therapy interventions. all participants will rate their psychological states pre- and post-mri exams. their physiological data will be recorded during the examination. after the scanning, they will complete an experience review.

Eligibility criteria:
inclusion criteria: 1. the subject is diagnosed with cancer; 2. the subject is between 18- 60 years old; 3. the subject understands mandarin, cantonese, or english; 4. the subject did not use medication for sedatives, anxiolytics, and/or sleep aids; 5. the subject is awake without cognitive disorders; 6. the subject rates more than 0 on the 0-10 vas for anxiety; 7. the subject has finished primary school level education. exclusion criteria: 1. the subject withdraws the mri scan; 2. the subject needs other intervention(s) to complete the scan; 3. the subject has hearing and/or visual impairments; 4. the subject has a history of a severe somatic psychiatric disease or clinically diagnosed mental disorders.

Keywords: mri anxiety symptom distress relaxation music therapy
oral-motor assessment and rehabilitation mobile app (orar app)

Conditions: Stroke; Oral Motor Functions

Summary: the goal of this study is to set up a database of oral-motor and speech functions of post-stroke patients in hong kong via an artificial intelligence-powered mobile-health application. the main study objectives are: 1. to establish an image database of oral-facial movements of neurologically healthy adults and adult stroke patients in hong kong. 2. to evaluate the oral-motor functions of neurologically healthy adults and stroke patients via instrumental and behavioral assessment. 3. to investigate the correlation between image-based analysis of oral-facial functions and instrumental evaluations and subjective judgment by the speech-language therapist.


Eligibility criteria:
for neurologically healthy adults, inclusion criteria: 1. age between 20 and 85 years old; 2. no severe systemic diseases such as uncontrolled diabetes, cerebrovascular diseases, head and neck tumors, or neurological disorders; 3. not undergoing radiation therapy or chemotherapy; 4. normal or corrected-to-normal vision and hearing; and 5. fluent cantonese speakers exclusion criteria: 1) participants who are unable to sign the "informed consent form" due to cognitive impairments for stroke patients, inclusion criteria: 1. age between 20 and 85 years old; 2. a history of stroke; 3. not undergoing radiation therapy or chemotherapy; 4. normal or corrected-to-normal vision and hearing; 5. premorbid fluent cantonese speakers; and 6. able to follow simple commands. exclusion criteria: 1. individuals currently on non-oral feeding; and 2. participants who are unable to sign the "informed consent form" due to cognitive impairments

Keywords: mobile app stroke oral motor functions rehabilitation artificial intelligence speech
safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ascending doses of arn 509 in combination with abiraterone acetate

Conditions: Prostate Cancer

Summary: this is a phase ib, open label study of arn-509 administered in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer.


Eligibility criteria:
key inclusion criteria: * participants must have histologically confirmed prostate cancer. * radiographic evidence of metastatic disease, detectable by bone scan, ct scan, or mri. at least one site of metastatic disease must be amenable to needle biopsy. * castrate levels of testosterone (testosterone \< 50 ng/dl) on androgen deprivation therapy (adt). patients who have not undergone orchiectomy will continue gonadotropin releasing hormone (gnrh) agonist or antagonist therapy. * age \> 18 years * ecog performance status \< 2 * evidence of disease progression on adt. patients must have two serial rises in psa from nadir, with at least 1 week between psa measurements, with a minimum psa of 2 ng/ml, or patients must have radiographic evidence of progression. nadir is defined as the lowest psa value after beginning the most recent therapy for metastatic crpc. key exclusion criteria: * participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * participants may not be receiving any other study agents. * participants with known brain metastases * any history of seizure or a condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign cns or meningeal disease which may require treatment with surgery or radiation therapy). * concurrent therapy with medications known to have seizure potential (those must have been discontinued or substituted for at least 28 days prior to starting the trial) * concurrent treatment with strong cyp3a4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice) or inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, st. john's wort) * history of pituitary dysfunction * history of adrenal dysfunction * requirement for steroid use greater than 10 mg of prednisone daily * history of gastrointestinal disorder or prior extensive gastrointestinal surgery that may interfere with sufficient absorption of the study compounds. * prior history of cyp17 inhibitors (e.g., abiraterone acetate, tak-700) and second-generation anti-androgen (e.g., mdv3100)

Keywords: metastatic castrate resistant prostate cancer (crpc)
efficacy study of acupuncture on spinal compression fracture

Conditions: Spinal Compression Fracture

Summary: this study is to investigate the effectiveness of acupuncture for alleviating pain from spinal compression fracture in patients treated with nerve block.

spinal compression fracture is mainly caused by trauma, furthermore, in old age, osteoporosis increases the risk of spinal compression fracture. nerve block is effective for the management of pain from inflammation or nerve root stimulation from spinal compression fracture. as one of alternative interventions, acupuncture is effective for controlling spinal compression fracture. this study aims to investigate that combination with acupuncture and nerve block may relieve spinal compression fracture-related pain versus nerve block alone.

Eligibility criteria:
inclusion criteria: * vertebral compression fracture by trauma or osteoporosis * minimum 15% height loss of vertebrae * patient diagnosed with x-ray or computed tomography (ct) or magnetic resonance image (mri) * visual analogue scale (vas) score of 5 or more * age over 50 * 2 weeks from onset or more * follow-up possible during the clinical trial * written informed consent voluntarily exclusion criteria: * within 2 weeks from onset * pathological fracture due to malignancy/myeloma, osteomyelitis * major retropulsion of bony segments into the spinal canal * bone metabolic disease * significant renal or hepatic disease * hypersensitive reaction to acupuncture treatment * senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders * alcohol/drug abuse
corticosteroid combining noncorticosteroid systemic immunomodulatory therapy in vkh

Conditions: Vogt Koyanagi Harada Disease (VKH)

Summary: the aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (ncsit) for the treatment of vogt koyanagi harada disease (vkh).

vogt koyanagi harada disease (vkh) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. vkh patients given prednisone monotherapy are prone to relapse. noncorticosteroid systemic immunomodulatory therapy (ncsit) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. adalimumab, humanized monoclonal anti-tnf-α antibody, have demonstrated the efficacy of noninfectious uveitis. several randomized controlled trials have proved the efficacy and safety of ncsit such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown. the investigators propose to explore the effect, safety and optimal dose of prednisone combining ncsit in the treatment of vkh.

Eligibility criteria:
inclusion criteria: * diagnosis is based on revised international diagnostic criteria (read et al. 2001b). * age from 12 to 70 years old. * patients have no contraindication of prednisone and immunosuppressive therapy, as determined by the investigator based on the results of laboratory and physical examinations. * written informed consent is provided. exclusion criteria: * patients with other ocular diseases or fundus diseases: diabetic retinopathy, neovascular/wet age-related macular degeneration * history of renal or hepatic insufficiency, heart failure, systemic inflammatory disease or any other condition that, in the opinion of the investigator, would put the patients at risk by participating in the protocol. * history of infectious disease like chronic or active hepatitis b infection, hiv infection, immunodeficiency syndrome, chronic recurring infections, or active tuberculosis. * female patients who were pregnant or considering becoming pregnant during the study.
observational study of the long-term effect of macugen in patients with wet age-related macular degeneration

Conditions: Macular Degeneration; Age-related Macular Degeneration; Neovascular Macular Degeneration

Summary: long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (amd) under macugen treatment.

ophthalmologists who are experienced in doing intravitreal injections in germany

Eligibility criteria:
inclusion criteria: * patients with neovascular age-related macular degeneration exclusion criteria: * none

Keywords: prospective observational phase 4 non-interventional open-label
understanding the late effects of surviving a pediatric brain tumor

Conditions: Brain Tumor; Pediatric Brain Tumor; Pediatric Cancer

Summary: the goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.


Eligibility criteria:
inclusion criteria: children treated for posterior fossa tumors: * as per medical record or clinical report, successfully completed all medical treatment for either an m0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease. * for medulloblastoma survivors only: previously treated with gross total resection (gtr), craniospinal irradiation with conformal posterior fossa boost radiotherapy (csi + boost) and chemotherapy * for low grade astrocytoma survivors only: previously treated with gross total resection only (no chemotherapy or radiotherapy). * as per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor. * subject is between the ages of 6 through 16 years at time of consent. * as per medical record or parent report, subject is able to tolerate an mri without sedation. healthy control participants: * no major medical illness, as determined by medical interview by study physician. * as per parent report, subject is between the ages of 6 through 16 years at time of consent. * as per parent report, subject is able to tolerate an mri without sedation. exclusion criteria: all participants: * full scale iq as documented to be below a standard score of \<70 based upon the study iq assessment completed after consent. * as per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year. * mri contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures. * as per self or parent report or medical record, currently taking medications that have cns effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma). * as per self or parent report, non-fluency in english language as demonstrated by current educational placement in a non-english-speaking classroom setting.

Keywords: 17-338 cognitive function behavioral function
integrated tele-monitoring and patient-centric health coaching strategy in patients hospitalized with heart failure

Conditions: Heart Failure

Summary: this study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.

tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. the monitoring system remotely monitors electrocardiographic (ecg) signals, heart rate, breathing rate, and activity levels. additional devices will be integrated with the monitoring device to assess blood pressure and weight. health coaching involves a team of health care professionals including a registered nurse (rn). the health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. the data collected by the remote monitoring device will assist the care team in patient management.

Eligibility criteria:
inclusion criteria: * hospitalized with primary or secondary diagnosis of acute decompensated heart failure (one or more of these symptoms: shortness of breath, orthopnea or edema and one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) * adult patients \>18 years old exclusion criteria: * overall life expectancy \< 1 year * known skin allergy to adhesives (hydrocolloid, silicone, acrylic) * active systemic infection * pregnant or lactating * end stage renal disease on dialysis * subject or caregiver is not visually and tactile capable of smartphone and home device usage * inadequate cell phone coverage (including international patients or international travel during study period) * subject or legal guardian is not willing and able to provide appropriate informed consent
pilot study of radiofrequency ablation of breast cancer lumpectomy sites to decrease re-operation

Conditions: Cancer of the Breast

Summary: in this protocol we combine two available and reliable treatments - lumpectomy and rfa. this combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. this combined open technique will allow for full histologic analysis of the primary tumor and margin. because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

while rfa alone is not approved for tumor destruction in breast it is fda-approved for ablation of soft tissue after the breast cancer is removed. this study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. the primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. rfa ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Eligibility criteria:
inclusion criteria: * female, 18-100 years old * not pregnant or breastfeeding * pre-study radiologic documentation of: * size ≤ 5 cm * unicentric, unilateral * suspicious mass or calcification * birads classification ≥ iv * location of abnormality \> 1 cm from skin * ductal or infiltrating ductal carcinoma * grade i-iii on final pathology * good general health * zubrod performance status of 0,1, or 2 * no previous chemotherapy * no palpable axillary or supraclavicular lymph nodes * if prior non-breast malignancy, must have \> 5 year disease-free survival exclusion criteria: * patient \ 100 y/o * pregnant or breastfeeding * male * breast implants * multicentric disease or bilateral disease * lesions \> 5 cm in diameter * lesions \< 1.0 cm from the skin * previous prior radiation to the breast * need for mastectomy * diffuse microcalcifications (as determined by the investigator)

Keywords: breast cancer lumpectomy radiofrequency ablation negative margins breast conserving surgery